Rahul Shetty

About Rahul Shetty

Adhere to change management SOP, GxP compliance, SDLC, Computer System Validation (21 CFR Part 11, GAMP 5) requirements.(V Model approach), CDAS, eDMS • Demonstrated history of experience at pharmaceutical sterile plants. Skilled in Pharmaceutics Validation Documents and Protocols, Initiation and Release of Preventive Maintenance, Calibration and Breakdowns in SAP. • Posting and recording details of process deviations through the company Trackwise system. • Undertaking investigations of process deviations with relevant Production, Engineering and Technical Support personnel to determine root cause of assigned issues. • Providing reports with detail as required to effectively record and close out investigations and assessments on Trackwise in a timely manner. • Developing and maintaining GAMP lifecycle documentation, including user requirement Specifications, functional specifications, risk assessments, and traceability matrices. • Performing gap analyses and risk assessments (GMP, GLP, GCP, 21 CFR Part 11). • Completed 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems. Closure of CFT complaints by providing relevant Production investigation to Quality on a timely basis. • Introduce process changes and improvements as appropriate to prevent recurrence of process deviations and complaints as determined by relevant investigations. • To perform all activities in accordance with current Good Manufacturing Practice (cGMP).

Experience

1. Validation Engineer

   Lupin

   Aug 2022 — Present · Mumbai, IN

   Working in IT Infotech at Lupin Head Office Mumbai.